1. Field of the Invention
The present invention relates to a method and system for creating and distributing sets of related documents.
Traditionally, documents are considered as discrete paper records representing textual or other information. In recent years, a broader definition of documents has been adopted that incorporates storage of the underlying document information in electronic form. That can include graphic or other information displays derived from separate computer programs and exported into a computer word processor program and stored as a single computer file in word processor format. Many documents are functionally linked to other documents that deal with a particular business or academic function and can be referred to as `Document Sets`.
Conventional word processor documents store document information in a form fundamentally different from the form used for storage of much of the other data related to the documents (e.g., other data on a business project). Accordingly, integration of the information contained in these disparate documents, Document Sets and databases is difficult, and frequently involves repeated entry of the same information into multiple data storage devices. The Author of a document generated by a word processor does not have easy guidance on the format and content requirements of a given document type. The Author also lacks electronic access to relevant information contained in other documents or databases. Electronic transmission of a document (e.g., via computer networks) is performed by transmission of the entire electronic file for the document, regardless of whether some components of the electronic file are already present at the computer site receiving the document.
For example, Clinical Research Studies of a new drug for use in human disease require a Document Set for each Clinical Study. Each such Clinical Study requires a number of `documents` that are primarily text-based descriptions of various Clinical Study features, such as design and implementation agreements, instructions, and records of implementation of the Clinical Study. The central document for a Clinical Study is the `Protocol` which is a written description of how the Clinical Study will be conducted by an Investigator studying the drug in normal volunteers or patients with disease. In addition, other documents related to Clinical Studies are required. Documents in Clinical Study Document Sets are largely based on the underlying design of the Clinical Study, as represented by a series of actions performed at specified times.
It is therefore desirable to generate Document Sets in a manner that facilitates document creation, integration with other databases, efficient transfer of documents and related files between computers, linkage of related documents so as to access information from a common store, and enforcement of standards to be applied to such documents.
2. Description of the Prior Art
Documents are conventionally generated using either a typewriter or a computer word processor, but these methods have the disadvantage that they do not provide, or have limited capacity for, the following:
Relational Database: Storage within a relational database of document data, structural information, rules and Dependencies, so as to permit linking of comparable data residing in different sections of an individual document or in different documents, sophisticated searching, integration and analysis of the data, and analysis of data across multiple Document Sets. In addition, storage of document data in a relational database facilitates exchange of information between non-document relational databases that contain information functionally related to the information in the documents. PA1 Time/Action Electronic Matrix: A central control mechanism for Document Sets based on an electronic matrix of time periods and associated actions. PA1 Enhanced Electronic dissemination of Documents: Transfer of a document between computers by confining transmission to those portions of a document that are document-specific--i.e., those portions that are not shared by all other documents of the particular type. PA1 Automatic regeneration of Dependent documents or document components: Dependency of a document or document section implies that it requires updating when a given data item shared within or across documents is changed. PA1 Automatic updating and reconciliation of Data: Data from different documents within a Document Set or across multiple Document Sets can be automatically updated and reconciled. PA1 Enforcement of Format and Content Requirements: Computer-controlled mechanism for avoiding document format violations and document information omissions. PA1 Clinical Study Protocol. PA1 Investigator-Related Documents: Investigator Protocol Approval Forms, Correspondence, Telephone Contact Form, Site Visit Report Forms, Investigator Check Lists, Investigator Instructions. PA1 Patient Documents: Patient Instructions, Documents to record Other Patient Data. PA1 Regulatory Authority Documents: Clinical Study Summary; Integrated Summary of Safety; Integrated Summary of Efficacy; Other IND and NDA documents; Correspondence. PA1 Serious Adverse Event (SAE) Documents: SAE Protocol Inventory Form, SAE Patient Report Form. PA1 Budget Documents: Generic Budget, Investigator-specific Budget. PA1 Informed Consent Form (ICF) Documents: Generic and Investigator-specific ICFs. PA1 Other Internal Sponsor Documents: Memoranda; Internal Check Lists; Internal Approval Forms (for Protocol, ICF, budget, Case Report Form, drug supply request). PA1 Other Document Types: Case Report Order Form, Drug Supply Order Form, Sample Size Estimation Form. PA1 In accordance with further embodiments of the present invention, Document Sets are generated using, as a central control mechanism, a Time/Action Electronic Matrix representing time (the period during which actions take place) and actions (evaluations, interventions or other actions taken or performed during the project to which the Document Set relates). The full data in the Time/Action Electronic Matrix may be visually represented in a `Flow Chart` table that can be incorporated directly into another document. The various documents in the Document Set utilize the information in this matrix. The matrix is represented as a set of electronic data locations. The intersection of each time-point/action pair is represented by a `cell`. The cell indicates whether or not the action is to be performed at the specified time point. When the Time/Action Electronic Matrix has been designed by the Author, the Dependent components of the various documents in the Document Set (i.e., those text sections which are dependent on the entered matrix data) are automatically available. The document text sections are independently accessed by the Author for insertion of the remaining text. PA1 According to a further embodiment of the present invention, data storage in a relational database can be used to provide a more efficient method of transmitting files electronically by computer networks or by physical transfer of copies residing in electronic storage media. Computer networks such as the Internet (a publicly available worldwide network of computers) and Intranets (organization-specific proprietary computer networks that may also access the Internet) have a significant and increasing problem of `bandwidth` creating a bottleneck in the speed of data transmission. Other workers have developed methods for compacting the information within an individual computer file (e.g., a word processor file) but have not addressed the possibility of eliminating redundant information across documents of a particular document type. Documents of a specific document type may all contain common formatting information or common text sections that substantially increase the size of the electronic document file. The example of a document provided as Protocol Document Listing I has file sizes of 66 kilobytes (KB) as a conventional Microsoft Word file, 26 KB as a simple text (ASCII) file, and 16 KB as a file confined to the document-specific components of the file (i.e., eliminating both formatting information and text segments shared by the Protocol document type). Even greater file size savings can be obtained by eliminating redundant information stored at multiple document locations at which shared information is placed (i.e., common information stored in the document database and inserted in multiple places within the document). Utilizing the present invention, the document-specific information stored in the relational database can also be stored and transmitted in a more compact data format using the C++ computer software classes that can be used in the method and system of the present invention to link the data in the relational database to the word processor templates that will generate the complete documents.
For Clinical Research Studies, the following document types share linked information:
A `Sponsor` of a Clinical Study is the organization responsible for filing the Clinical Study with the Food and Drug Administration (`FDA`) and is normally a pharmaceutical company. Most Sponsors use a word processor to write Protocols and other documents required in a Clinical Study, frequently by copying sections of previous documents and editing these. The `Author` (i.e., the person writing the Protocol) is not forced during Protocol writing to address all of the key items in writing a Protocol, so that major omissions and errors may be frequent. Even though a Sponsor may have a `standard format` for Protocols, this may not be followed by Authors--so that the task of those reviewing and approving the Protocol is more difficult. Photocopies of the Protocol are normally distributed for internal review and for hand-written comments to be written on the copy. The Protocol exists as a word processing file that limits search capabilities (e.g., dosage used across Protocols). Normally a separate form containing key Protocol items for the Sponsor's Serious Adverse Event database is hand-generated and these data are then entered into a separate computer database. Many disparate Clinical Study databases exist in pharmaceutical companies and integration of these databases has become a significant issue with the pharmaceutical industry and FDA--with significant medico-legal and regulatory implications.